French drug company Sanofi SA (>> SANOFI) Monday said results from the pivotal Phase III Velour study evaluating Zaltrap showed improvement in overall survival rate to colorectal cancer.
- Sanofi said the Journal of Clinical Oncology published the results of the study evaluating Zaltrap effects.
- In the Velour trial evaluating metastatic colorectal cancer patients previously treated with an oxaliplatin-containing regimen, Zaltrap in combination with the Folfiri chemotherapy regimen (5-fluorouracil, leucovorin, irinotecan) showed a statistically significant improvement in overall survival, progression-free survival, and the overall tumor response rate versus placebo plus Folfiri.
- The Velour data supported the regulatory approval of Zaltrap by the U.S. Food and Drug Administration (FDA) on August 3, 2012 after a Priority Review.
- Zaltrap is under review at the European Medicines Agency and other regulatory agencies worldwide, Sanofi says.
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